The Effect of Pulse Oximeter Probe Replacement Interval on Pressure Injury Development in Intensive Care Patients
"The Effect of Pulse Oximeter Probe Replacement Interval on Pressure Injury Development in Intensive Care Patients: A Randomized Controlled Trial"
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Pulse oximetry is a non-invasive monitoring method that continuously measures arterial oxygen saturation (SpO₂) and pulse rate using optical sensors placed on peripheral tissues. It is widely used in intensive care units (ICUs), operating rooms, and other critical care settings for continuous patient monitoring . Although essential for patient care, prolonged application of pulse oximeter probes to the same anatomical site may increase the risk of medical device-related pressure injuries (MDRPIs), particularly in critically ill patients with impaired tissue perfusion, immobility, and fragile skin.
Medical device-related pressure injuries represent a substantial proportion of hospital-acquired pressure injuries and are associated with increased morbidity, prolonged hospitalization, and healthcare costs. International clinical practice guidelines recommend frequent skin assessment, regular repositioning of medical devices, prompt removal of unnecessary devices, and interventions to reduce pressure. However, these guidelines do not define an evidence-based interval for repositioning pulse oximeter probes, and current clinical practice varies considerably among healthcare institutions.
Several case reports have described tissue injury associated with prolonged pulse oximeter sensor application, including skin erosion and tissue necrosis at the finger, toe, ear, and forehead. Nevertheless, high-quality randomized controlled trials evaluating the optimal pulse oximeter probe replacement interval are lacking.
The primary objective of this randomized controlled trial is to determine whether different pulse oximeter probe replacement intervals influence the incidence of pressure injuries in adult ICU patients. The findings are expected to provide evidence for establishing standardized clinical protocols for pulse oximeter probe repositioning and contribute to the prevention of medical device-related pressure injuries in critically ill adults.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ankara, Turquie (Türkiye)
- Univerisy of HelathSciences Turkiye Gulhane Faculty of Nursing
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18 years or older
- Written informed consent provided by the patient's legally authorized representative
- Patients monitored with a pulse oximeter in the intensive care unit (ICU)
- Glasgow Coma Scale (GCS) score of 8 or less
- Expected or actual ICU stay of more than 72 hours
Exclusion Criteria:
- Patients with severe peripheral edema
- Patients with dermatological conditions that impair skin integrity
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention Group
Patients will have a pulse oximeter probe placed on the right index finger.
The probe site will remain unchanged for 2 hours.
At the end of the 2-hour period, the probe will be removed, and the skin will be assessed for pressure injury using the Skin Assessment Form.
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The pulse oximeter probe will be placed on the patient's right index finger and repositioned every 2 hours.
After 2 hours, the probe will be removed, the skin will be assessed for pressure injury using the Skin Assessment Form, and the probe will be repositioned according to the study protocol.
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Comparateur actif: Control Group
Patients will receive routine intensive care.
The pulse oximeter probe will remain in the same position for 4 hours, consistent with standard ICU practice.
At the end of the 4-hour period, the probe will be removed, and the skin will be assessed for pressure injury using the Skin Assessment Form.
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The pulse oximeter probe will remain in the same position for 4 hours in accordance with routine intensive care unit practice.
After 4 hours, the probe will be removed, the skin will be assessed for pressure injury using the Skin Assessment Form, and routine care will continue.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Incidence of Medical Device-Related Pressure Injury at the Pulse Oximeter Probe Site
Délai: Up to 4 hours after pulse oximeter probe placement
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The primary outcome is the incidence of medical device-related pressure injury (MDRPI) associated with pulse oximeter probe application in adult intensive care unit patients. Skin assessments will be performed using the Skin Assessment Form developed by the investigators based on the literature and the European Pressure Ulcer Advisory Panel (EPUAP) guidelines. The assessment includes: Presence or absence of medical device-related pressure injury Non-blanchable erythema Skin moisture Skin integrity Presence and severity of edema Tissue firmness Palpation findings Local skin temperature changes Pressure injury stage (Stage 1, Stage 2, Stage 3, Stage 4, Deep Tissue Injury, or Unstageable) The incidence of pressure injury will be compared between patients whose pulse oximeter probe is repositioned every 2 hours and those whose probe is repositioned every 4 hours. |
Up to 4 hours after pulse oximeter probe placement
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1616161616
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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